Associate Scientist, QCA - PM Shift

Novartis

On-site

Morris Plains, NJ

$66,780 - $124,020 USD yearly

Operations

Under general direction, perform testing and other activities in functions supporting the Quality Control department (QC Bioassay).

Location: This position is on-site in Morris Plains, NJ.

PM Shift: 12-hour 4/3 shift (alternates every other week). Week 1: Wednesday–Saturday, 3:30 PM–3:30 AM; Week 2: Thursday–Saturday, 3:30 PM–3:30 AM.

Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, cell viability, sterility testing, endotoxin, and mycoplasma.
Maintain controls and reference standards to support testing.
Follow quality policies.
Plan and schedule assigned activities.
Review/approve data generated by other team members.
Perform method qualification/optimization of methods as per appropriate protocols.
Contribute to OOS/OOE investigations and deviation investigations.
Support 5S and Lean projects.
Identify potential improvements in project work.
Interface with regulatory agencies during audits.
Contribute to assigned projects.
Knowledge of LabWare LIMS and/or other QC data systems. Maintain GMP/GLP quality systems.
Provide coverage for all appropriate areas and testing.
Performs other job duties as assigned.

0 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
Knowledge of cGMP and an understanding of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (e.g. ANSI, ISO).
Knowledge of bioassay test methods, as appropriate.
Knowledge of LIMS systems.
Ability to communicate clearly with a variety of individuals in various aspects of operations.
Detail-oriented with expertise in problem solving and solid decision-making abilities.
Strong interpersonal skills and professional demeanor.
Strong written and verbal communication skills.

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